The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States … Continue Reading

The Food Safety Modernization Act ("FSMA") significantly expands the FDA’s ability to access a food company’s records. The expanded authority is found in three places in the statute: FSMA § 101 amends 31 USC § 350c(a) and allows the FDA to obtain records related not only to a product that the FDA believes "will cause … Continue Reading

The E. coli outbreak unraveling now in the European Union, centered primarily in Germany, is setting new records for both the number of affected persons and the number of persons diagnosed with Hemolytic Uremic Syndrome (HUS), a serious complication from E. coli infection (HUS can lead to kidney failure, brain damage and death). As of … Continue Reading

Thank you to Parker Smith & Feek for inviting me to speak to about FSMA and how it’s changing the status quo. My slide-deck can be viewed here. Following my talk, Marty Bask from Parker Smith & Feek led a very interesting discussion about the pros and cons of product recall and contamination coverage. A link … Continue Reading

I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News: As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation. Once a … Continue Reading

On February 24, 2011, Lee Smith and I presented "How Regulatory Changes Affect Litigation Risks" to the Grocery Manufacturers Association’s food litigation conference. A link to the slide-deck can be found here. We discussed ways that the Reportable Food Registry (RFR) and the Food Safety Modernization Act (FSMA) are affecting litigation now and can be … Continue Reading

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.). Beyond the statistics, the FDA report should be noted by food companies for two reasons: Food … Continue Reading

President Obama signed into law today the Food Safety Modernization Act (FSMA). Companies with facilities subject to FDA jurisdiction should take immediate steps to review and, where necessary, modify SOPs, policies and procedures. For example, given the FDA’s expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may … Continue Reading

For years, a debate has raged on the merits of vesting the FDA with mandatory recall powers. Mandatory recall is part of the food safety legislation that may or may not pass in this Congress, so it’s worth discussing. At present, the FDA lacks any power to order a recall. Its only legal authority is … Continue Reading

Ken posted an entry with the title: “Can Business Lawyers Afford to Practice ‘Defensively.’” I’ve been a business lawyer for almost 30 years, so I think I have at least some perspective on that issue and I thought I’d contribute to the discussion with some historical observations. I apologize in advance if I sound like I’m suggesting that … Continue Reading

Note: The following is authored by guest blogger Jake Storms, from the Alcoholic Beverages Law Blog. Amidst rising incidences of hospitalizations in college and teenage drinkers linked to consumption of alcoholic energy drinks, the Washington State Liquor Control Board banned their sale effective tomorrow, November 18, 2010. The move came on the heels of a … Continue Reading

Here’s a link to an article that appeared recently in Inside Washington’s FDA Week concerning the issue of front-of-package labeling (FOP). The article takes aim at the debate about state vs. federal regulation of FOP labeling. Here’s a link to a recent post in this blog on the FOP issue.… Continue Reading

Cheesemakers have endured a string of bad publicity recently over food safety. Cheesemakers, especially raw milk cheesemakers, are in the cross hairs of the FDA, the media, retailers and plaintiffs’ lawyers such as Bill Marler. I was interviewed last week on FDA seizure issues by the Pacific Northwest Cheese Project. Click here for the PowerPoint … Continue Reading

I appreciate why lawyers practice defensively. We are risk adverse as a profession. But is this what our clients want from us? After all, our clients are usually in a risk-taking position when they seek our advice in the first place. In today’s business climate, competition in almost ever sector is fierce to say the … Continue Reading

The FDA recently took the relatively unusual step of obtaining a court-issued warrant to seize all cheese products at Estrella Family Creamery, a small, family-owned artisan cheese maker in Washington State. According to the United States Attorney’s Office for the Western District of Washington, "the FDA asked Estrella to recall all cheese products. The company … Continue Reading

There is a niche market out there for celebrity-endorsed food products that benefit charities. PLB Sports out of Pittsburgh appears to be a market leader in this niche, labeling products ranging from beef jerky to salsa to mustard with images and slogans relating to both individual sports figures and teams. Probably the most famous of these were … Continue Reading

This article was first published on August 27, 2010 in Food Chemical News as part of its "On the Front Burner" series. In its first year, the FDA’s Reportable Food Registry has proven itself to be a high-stakes game changer. The ticking of the RFR’s 24-hour reporting deadline forces a company to make snap decisions … Continue Reading

The quote, "Watch what we do, not what we say," is attributed to John Mitchell, Nixon’s first attorney general. It can apply, however, to the behavior of consumers with respect to shrimp from the Gulf of Mexico, and that will be watched carefully everyone from shrimp fishers to the owners of your local fish market. The FDA … Continue Reading

This is the title of a presentation I’ll be giving at the American Cheese Society’s (ACS) annual meeting in Seattle. I’ll be speaking along with Marc Baker and Jill Perucca from the Elliott, Powell, Baden & Baker insurance agency at 3:30 p.m. on August 27. The slide deck I intend to use can be found … Continue Reading

FDA recently released updates to its Draft Industry Guidance for the Reportable Food Registry (“RFR”). The RFR, not rolled out until the fall of 2009, is still new to many companies. FDA, overwhelmed by the information coming through the RFR, is still trying to determine how to use the information submitted to the RFR and … Continue Reading

I’ll be moderating and speaking on a panel at the upcoming ACI’s Advanced Summit on Food Safety Regulatory Compliance in Chicago, June 28-29. Scott Rickman from Del Monte, public relations professionals and I will be presenting on "Effectively Responding to Negative Media Coverage: How to Avoid the Backlash" (If you plan to attend, register soon and contact … Continue Reading

As we have blogged about, litigation regarding product labeling has been a hot topic within the food and beverage industry. A recent decision from the Northern District of California could hold interesting implications for Lanham Act claims centering on the labeling of products as “organic.” While the case, One God Faith, Inc. v. Hain Celestial … Continue Reading

Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides. Take-aways from the second webinar include: • … Continue Reading

Melinda Beck has a terrific article in today’s Wall Street Journal about home remedies for the H1N1 virus and (as we have previously blogged) the FDA’s efforts to reign in those making unsupported marketing claims for their remedies. One remedy sweeping the blogosphere like wildfire is the use of onions to soak up flu bugs. … Continue Reading

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The Stoel Rives LLP Food Liability Law blog is a resource intended to provide its audience with commentary and analysis of the most current and significant issues affecting companies that import, manufacture, market, distribute and sell foods in the United States.
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About Stoel Rives LLP

Stoel Rives LLP is a U.S. law firm, with a full suite of transactional and litigation solutions for U.S. and international clients. Established in 1907, the firm has nearly 400 attorneys operating out of 11 offices in seven states and the District of Columbia. Representative clients include financial institutions, public and private utilities, energy and renewable energy companies, developers, manufacturers, retailers, hospitals, universities, agribusinesses, software companies, food and beverage companies, charitable foundations, telecommunications and forestry companies, among others. We represent businesses at all stages of growth, from start-ups to Fortune 500 companies.